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ECCO2R in the Treatment of Acute Exacerbation of COPD With Severe Hypercapnia

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ClinicalTrials.gov Identifier: NCT04842344
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Li Xuyan, Beijing Chao Yang Hospital

Study Description
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Brief Summary:
Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.

Condition or disease Intervention/treatment Phase
Lung Diseases, Obstructive Device: ECCO2R Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of Extracorporeal Carbon Dioxide Removal (ECCO2R) in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Severe Hypercapnia
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Noninvasive ventilation and ECCO2R Device: ECCO2R
extracorporeal carbon dioxide removal
No Intervention: Noninvasive ventilation


Outcome Measures
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Primary Outcome Measures :
  1. Demand rate of endotracheal intubation [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Actual rate of endotracheal intubation [ Time Frame: 28 days ]
  2. hospital mortality [ Time Frame: 28 days ]
  3. length of ICU stay [ Time Frame: 28 days ]
  4. length of hospital stay [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AECOPD patients.
  • The patients with hypercapnia respiratory failure were admitted to ICU and needed noninvasive ventilation.
  • The results of blood gas analysis showed pH <7.30, PaCO2> 50 mmHg.
  • There were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the pH value was ≤ 7.30, while PaCO2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate ≥ 30 times / min, assisted respiratory muscle breathing; contradictory breathing.
  • Informed consents were sighed.

Exclusion Criteria:

  • The mean arterial pressure was less than 60 mmHg after volume and vasoactive drug treatment.
  • There were anticoagulant contraindications.
  • Weight over 120kg.
  • Patients with malignant tumor or other complications, the expected survival time was less than 30 days.
  • It could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842344


Contacts
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Contact: Xuyan Li, MD 86013581851048 araklee@163.com
Contact: Bing Sun, MD 86013911151075 ricusunbing@126.com

Locations
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China
Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University Recruiting
Beijing, China, 100020
Contact: Xuyan Li    +8613581851048    araklee@163.com   
Sponsors and Collaborators
Li Xuyan
Investigators
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Principal Investigator: Bing Sun, MD Beijing Chao Yang Hospital
More Information
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Responsible Party: Li Xuyan, Sponsor Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04842344    
Other Study ID Numbers: 2020-KE-492
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Xuyan, Beijing Chao Yang Hospital:
Acute exacerbation of chronic obstructive pulmonary disease
extracorporeal carbon dioxide removal
Hypercapnia respiratory failure
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Hypercapnia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory